PulpitisNCT07638254
Buffered Versus Conventional Local Anesthesia for Pain and Anxiety Reduction in School-Aged Children With Pulpitis
A study testing Buffered Lidocaine with Epinephrine and idocaine with Epinephrine (Conventional) in people with Pulpitis, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- Buffered Lidocaine with Epinephrine and idocaine with Epinephrine (Conventional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 2 Mar 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 12 years
- Diagnosis of irreversible pulpitis due to dental caries in primary maxillary molars
- American Society of Anesthesiologists (ASA) Physical Status Classification I
- Cooperative or definitely cooperative behavior according to Frankl Behavioral Scale (Frankl III or IV)
- Written informed consent provided by parent or legal guardian, and child assent when applicable
- No use of analgesic or anti-inflammatory medication within 24 hours prior to the procedure
Who cannot join
- Known allergy to any component of local anesthetic solution
- History of negative or traumatic dental experiences within the previous 12 months that may interfere with behavioral assessment
- Radiographic evidence of periapical pathology associated with the affected tooth
- Presence of localized abscess or acute spreading infection at the injection site
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí, 78290
Mayte A Condori Chambi, Cirujano Dentista, 4446641295, maytecondori97@gmail.com
About this study
Official title: Efficacy of Buffered Versus Conventional Local Anesthesia for Reducing Pain and Anxiety During Dental Treatment in School-Aged Children Diagnosed With Pulpitis: A Randomized Controlled Clinical Trial
The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. The study will also assess differences in physiological and self-reported indicators of pain and anxiety, as well as anesthetic onset and duration.
The main questions it aims to answer are:
Read more
Does buffered local anesthesia reduce behavioral pain scores measured by the FLACC scale compared to conventional local anesthesia? Does buffered local anesthesia improve physiological and psychometric indicators of pain and anxiety during dental procedures?
Methodology: The researchers will compare buffered local anesthesia with conventional local anesthesia during routine dental treatment procedures such as pulpotomy or pulpectomy in primary molars.
Participants will:
Receive either buffered or conventional local anesthesia during dental treatment Undergo pulpotomy or pulpectomy depending on clinical diagnosis Be monitored for pain and anxiety using FLACC scale, heart rate, skin conductance, and Wong-Baker Faces Pain Scale at different stages of treatment Have the onset and duration of anesthesia recorded during and after the procedure Be followed until recovery of soft tissue sensation after treatment
- Conditions
- Pulpitis
- Being tested
- Buffered Lidocaine with Epinephrine, idocaine with Epinephrine (Conventional)
- Keywords
- Anesthesia, Dental, Anesthesia, Local, Buffers
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered Lidocaine with EpinephrineDrug
Local anesthetic solution buffered with sodium bicarbonate prior to administration in order to increase pH and potentially improve onset and patient comfort during dental procedures.
idocaine with Epinephrine (Conventional)Drug
Standard commercially available local anesthetic solution used in routine dental practice without pH modification
| Study group | Role | What they receive |
|---|---|---|
| Buffered Local Anesthesia | Experimental | Participants will receive buffered local anesthesia during dental treatment for pulpitis. The local anesthetic solution will consist of lidocaine with epinephrine combined with sodium bicarbonate to increase pH prior to administration. The intervention will be applied via local infiltration or nerve block as clinically indicated for pulpotomy or pulpectomy procedures in primary maxillary molars Receives: Drug: Buffered Lidocaine with Epinephrine |
| Conventional Local Anesthesia | Active comparator | Participants will receive conventional local anesthesia during dental treatment for pulpitis. The anesthetic solution will consist of lidocaine with epinephrine administered without buffering. The intervention will be applied via local infiltration or nerve block according to clinical indication for pulpotomy or pulpectomy procedures in primary maxillary molars. Receives: Drug: idocaine with Epinephrine (Conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC PAIN SCORE
Pain behavior will be assessed using the FLACC(Face, Legs, Activity, Cry, and Consolability) Scale score, during different phases of dental treatment in children with pulpitis receiving local anesthesia.
The scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain intensity and a worse outcome.
Measured: Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Secondary outcomes (5)
Physiological indicators (Heart Rate)
Description:
Heart rate will be recorded using a blood volume pulse (BVP) sensor during dental treatment.
Unit of Measure:
Beats per minute (bpm)
Measured: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Physiological indicators (Skin Conductance)
Description:
Skin conductance will be measured using electrodermal activity (EDA) sensors during dental treatment.
Unit of Measure:
MicroSiemens (µS)
Measured: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Wong-Baker Faces Pain Rating Scale Score
Self-reported pain whit Wong-Baker Faces Pain Rating Scale will be recorded at predefined clinical stages of treatment.
Scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst pain possible
Measured: Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Onset of local anesthesia
Description:
Time elapsed from completion of local anesthetic injection until confirmation of pulpal anesthesia. Pulpal anesthesia will be verified using cold testing (Endo Ice) after confirmation of soft tissue anesthesia.
Unit of Measure:
Minutes and seconds
Measured: From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit.
Duration of soft tissue anesthesia
Description:
Time elapsed from confirmed loss of soft tissue sensation following local anesthetic administration until complete recovery of sensation as reported by the participant's caregiver.
Unit of Measure:
Minutes
Measured: From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start2 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive one of two interventions during routine dental treatment: buffered local anesthesia or conventional local anesthesia. Clinical procedures may include pulpotomy or pulpectomy depending on diagnosis. Pain, anxiety, and anesthetic efficacy outcomes will be assessed during different phases of treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Guzmán Uribe, Universidad Autonoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638254
- Sponsor's protocol ID
- CEI-FE-041-025
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aulestia-Viera PV, Braga MM, Borsatti MA. The effect of adjusting the pH of local anaesthetics in dentistry: a systematic review and meta-analysis. Int Endod J. 2018 Aug;51(8):862-876. doi: 10.1111/iej.12899. Epub 2018 Feb 21.
PubMed 29377171Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.
PubMed 30087760
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Buffered Versus Conventional Local Anesthesia for Reducing Pain and Anxiety During Dental Treatment in School-Aged Children Diagnosed With Pulpitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07638254
- Acronym / sponsor ID
- CEI-FE-041-025
- Conditions
- Pulpitis
- Keywords
- Anesthesia, Dental, Anesthesia, Local, Buffers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. The study will also assess differences in physiological and self-reported indicators of pain and anxiety, as well as anesthetic onset and duration.
The main questions it aims to answer are:
Does buffered local anesthesia reduce behavioral pain scores measured by the FLACC scale compared to conventional local anesthesia? Does buffered local anesthesia improve physiological and psychometric indicators of pain and anxiety during dental procedures?
Methodology: The researchers will compare buffered local anesthesia with conventional local anesthesia during routine dental treatment procedures such as pulpotomy or pulpectomy in primary molars.
Participants will:
Receive either buffered or conventional local anesthesia during dental treatment Undergo pulpotomy or pulpectomy depending on clinical diagnosis Be monitored for pain and anxiety using FLACC scale, heart rate, skin conductance, and Wong-Baker Faces Pain Scale at different stages of treatment Have the onset and duration of anesthesia recorded during and after the procedure Be followed until recovery of soft tissue sensation after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will receive one of two interventions during routine dental treatment: buffered local anesthesia or conventional local anesthesia. Clinical procedures may include pulpotomy or pulpectomy depending on diagnosis. Pain, anxiety, and anesthetic efficacy outcomes will be assessed during different phases of treatment.
| Arm | Type | Receives |
|---|---|---|
| Buffered Local Anesthesia | Experimental | Drug: Buffered Lidocaine with EpinephrineParticipants will receive buffered local anesthesia during dental treatment for pulpitis. The local anesthetic solution will consist of lidocaine with epinephrine combined with sodium bicarbonate to increase pH prior to administration. The intervention will be applied via local infiltration or nerve block as clinically indicated for pulpotomy or pulpectomy procedures in primary maxillary molars |
| Conventional Local Anesthesia | Active comparator | Drug: idocaine with Epinephrine (Conventional)Participants will receive conventional local anesthesia during dental treatment for pulpitis. The anesthetic solution will consist of lidocaine with epinephrine administered without buffering. The intervention will be applied via local infiltration or nerve block according to clinical indication for pulpotomy or pulpectomy procedures in primary maxillary molars. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6 to 12 years
- Diagnosis of irreversible pulpitis due to dental caries in primary maxillary molars
- American Society of Anesthesiologists (ASA) Physical Status Classification I
- Cooperative or definitely cooperative behavior according to Frankl Behavioral Scale (Frankl III or IV)
- Written informed consent provided by parent or legal guardian, and child assent when applicable
Key exclusion criteria (4 listed)
- Known allergy to any component of local anesthetic solution
- History of negative or traumatic dental experiences within the previous 12 months that may interfere with behavioral assessment
- Radiographic evidence of periapical pathology associated with the affected tooth
- Presence of localized abscess or acute spreading infection at the injection site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buffered Lidocaine with EpinephrineLocal anesthetic solution buffered with sodium bicarbonate prior to administration in order to increase pH and potentially improve onset and patient comfort during dental procedures. | Drug | Buffered Local Anesthesia |
| idocaine with Epinephrine (Conventional)Standard commercially available local anesthetic solution used in routine dental practice without pH modification | Drug | Conventional Local Anesthesia |
Primary outcome
FLACC PAIN SCORE
Time frame: Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Pain behavior will be assessed using the FLACC(Face, Legs, Activity, Cry, and Consolability) Scale score, during different phases of dental treatment in children with pulpitis receiving local anesthesia. The scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain intensity and a worse outcome.
5 secondary outcomes
Physiological indicators (Heart Rate)
Time frame: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Physiological indicators (Skin Conductance)
Time frame: Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Wong-Baker Faces Pain Rating Scale Score
Time frame: Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
Onset of local anesthesia
Time frame: From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit.
Duration of soft tissue anesthesia
Time frame: From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 29377171Aulestia-Viera PV, Braga MM, Borsatti MA. The effect of adjusting the pH of local anaesthetics in dentistry: a systematic review and meta-analysis. Int Endod J. 2018 Aug;51(8):862-876. doi: 10.1111/iej.12899. Epub 2018 Feb 21.
- Background: PubMed 30087760Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.
Related trials for Pulpitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buffered Lidocaine with Epinephrine and idocaine with Epinephrine (Conventional) in people with Pulpitis, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mayte A Condori Chambi, Cirujano Dentista (+524446641295, maytecondori97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC PAIN SCORE (time frame: Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07638254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.